Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer (TEAM)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: tamoxifen; Drug: exemestane

Study type: Interventional

Funder types: Industry

Identifiers

NCT00279448

A5991081

EXEAPO-0028-118

Details and patient eligibility

About

To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1

Enrollment: 9,779 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HR+ post-menopausal patients with non-metastatic breast cancer

Exclusion criteria

• Any of the following: HR-, non-menopausal patient, metastatic breast cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,779 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: exemestane

B

Active Comparator group

Treatment:

Drug: tamoxifen